Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-03-31

Brief Summary

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The purpose of this study is to investigate if early administration (i.e. within 12 weeks after stroke) of Dysport® 500 U injections may delay the appearance or the progression of upper limb symptomatic spasticity.

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Detailed Description

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Conditions

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Stroke Upper Limb Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment group

Dysport® 500U intramuscular injection

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type BIOLOGICAL

Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb.

Placebo Group

Placebo intramuscular injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered intramuscularly in the targeted upper limb.

Interventions

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Botulinum toxin type A

Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb.

Intervention Type BIOLOGICAL

Placebo

Placebo administered intramuscularly in the targeted upper limb.

Intervention Type DRUG

Other Intervention Names

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AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

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Inclusion Criteria

* 2 to 12 weeks after first ever stroke according to the World Health Organisation criteria (previous transient ischaemic attack or clinically silent infarct on computerised tomography (CT)/magnetic resonance imaging (MRI) are not counted as previous stroke)
* Stroke confirmed by CT/MRI scan and classified as ischaemic/haemorrhagic stroke
* Presence of spasticity:

* either symptomatic, based on symptomatic spasticity criteria (i.e. at least one of the following items: impacted passive/active function, involuntary movements, or pain ≥4 on a numeric pain rating scale \[NPRS\]), in addition to increased muscle tone \[Modified Ashworth Scale, MAS ≥2\])
* or only increased muscle tone (MAS≥2)

Exclusion Criteria

* Neuromuscular junction (NMJ) diseases, or any other neurological disorders (including prior local joint, tendon, and intrinsic muscle disorders) that could potentially interfere with assessment of spasticity in the primary targeted muscle group selected by the Investigator and in agreement with the subject
* Currently receiving drugs affecting NMJ transmission e.g. aminoglycosides, aminoquinolines, cyclosporine, D penicillamine
* Previous surgery of the affected muscles/ ligaments/tendons
* Severe comorbidities (e.g. congestive heart failure, myocardial infarction, multiple organ failure, hepatic renal failures, severe infections)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No